Chronic PainNCT04689646
Mind Body Syndrome Therapy for Chronic Pain
A study testing Mind Body Intervention 1 and Mind body intervention 2 in people with Chronic Pain and Chronic Pain Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Chronic Pain, Chronic Pain Syndrome
- What is being tested?
- Mind Body Intervention 1 and Mind body intervention 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 6 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient 18 ≥ years old
- Chronic back pain
- Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
- Willingness to consider mind-body intervention
- At least score of 2 or more on Roland Disability Questionnaire
- At least score of 3 or more back pain bothersomeness
Who cannot join
- Patients < 18 years of age
- Patients > 67 years of age
- Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments)
- Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia, and bipolar disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Mind Body Syndrome Therapy for the Treatment of Chronic Pain
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
Read the detailed description
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
- Conditions
- Chronic Pain, Chronic Pain Syndrome
- Being tested
- Mind Body Intervention 1, Mind body intervention 2
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Body Intervention 1Behavioural
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Mind body intervention 2Behavioural
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Intervention 1 | Experimental | Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1. Receives: Behavioral: Mind Body Intervention 1 |
| Mind-Body Intervention 2 | Active comparator | Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2. Receives: Behavioral: Mind body intervention 2 |
| Usual Care | No intervention | Participants will continue their usual care for 26 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Disability
Roland Morris Disability Index (Scale 0-24 with 24 being worst)
Measured: 26 weeks
Secondary outcomes (6)
Average pain
Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)
Measured: Baseline, 4, 8, 13, and 26 weeks after initiation of the study.
Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey
Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Anxiety from pain
Anxiety from pain as determined from the Pain Anxiety Symptom Scale-20 survey (20 questions with scale of 0-5 with 5 being 'always' and 0 being 'never'
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Resolution of pain disability
Resolution of pain disability as measured by 0 or 1 on Roland Morris Disability (Scale 0-24 with 24 being worst)
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Pain affecting enjoyment of life
Scale 0-10 with 10 being worst from Brief Pain Inventory
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Resolution of back pain bothersomeness
Resolution of back pain bothersomeness as measured as 0-1 on scale 0-10
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start20 May 2021
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Donnino, Beth Israel Deaconess Medical Center
- Investigators
- Michael Donnino, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689646
- Sponsor's protocol ID
- 2020P000147
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2020
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Syndrome Therapy for the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT04689646
- Acronym / sponsor ID
- 2020P000147
- Conditions
- Chronic Pain, Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
Detailed description
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Intervention 1 | Experimental | Behavioral: Mind Body Intervention 1Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1. |
| Mind-Body Intervention 2 | Active comparator | Behavioral: Mind body intervention 2Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2. |
| Usual Care | No intervention | –Participants will continue their usual care for 26 weeks |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient 18 ≥ years old
- Chronic back pain
- Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
- Willingness to consider mind-body intervention
- At least score of 2 or more on Roland Disability Questionnaire
Key exclusion criteria (4 listed)
- Patients < 18 years of age
- Patients > 67 years of age
- Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments)
- Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia, and bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind Body Intervention 1Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions. | Behavioural | Mind-Body Intervention 1 |
| Mind body intervention 2Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions. | Behavioural | Mind-Body Intervention 2 |
Primary outcome
Pain Disability
Time frame: 26 weeks
Roland Morris Disability Index (Scale 0-24 with 24 being worst)
6 secondary outcomes
Average pain
Time frame: Baseline, 4, 8, 13, and 26 weeks after initiation of the study.
Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Anxiety from pain
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Resolution of pain disability
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Pain affecting enjoyment of life
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Resolution of back pain bothersomeness
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Donnino, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind Body Intervention 1 and Mind body intervention 2 in people with Chronic Pain and Chronic Pain Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Disability (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.